FDA 510(k)

R2P Destination Slender Guiding Sheath

Número K: K171491 · 2017-10-05

Data da decisão2017-10-05

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

R2P Destination Slender Guiding Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corporation. It received FDA 510(k) clearance on 2017-10-05 under 510(k) number K171491. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the R2P Destination Slender Guiding Sheath?

R2P Destination Slender Guiding Sheath is a medical device that received FDA 510(k) clearance on 2017-10-05. The listed applicant is Terumo Medical Corporation. The 510(k) number is K171491.

When did R2P Destination Slender Guiding Sheath receive FDA 510(k) clearance?

R2P Destination Slender Guiding Sheath received FDA 510(k) clearance on 2017-10-05, under 510(k) number K171491.

Who is the listed applicant for R2P Destination Slender Guiding Sheath?

The FDA 510(k) record lists Terumo Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for R2P Destination Slender Guiding Sheath?

The FDA product code for R2P Destination Slender Guiding Sheath is DYB.

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Fonte oficial

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